US10610548B2ActiveUtilityA1

Compositions comprising bacterial strains

91
Assignee: 4D PHARMA PLCPriority: Jul 13, 2016Filed: Jun 28, 2018Granted: Apr 7, 2020
Est. expiryJul 13, 2036(~10 yrs left)· nominal 20-yr term from priority
A61P 1/12A61K 9/0053A23L 33/135A61P 29/00A61K 9/19A61P 1/10A61K 2035/11A61K 35/74A23V 2002/00A61P 31/04A23V 2200/32A61K 9/0095A61K 39/0208A61K 9/48Y02A50/473Y02A50/30
91
PatentIndex Score
7
Cited by
1,231
References
17
Claims

Abstract

The invention provides compositions comprising one or more bacterial strains for treating preventing diarrhea and/or constipation.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A method of treating diarrhea, constipation, or diarrhea and constipation in a subject in need thereof, comprising administering to the subject a composition comprising: a bacteria strain, wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to SEQ ID NO:5, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62. 
     
     
       2. The method of  claim 1 , wherein the subject is human. 
     
     
       3. The method of  claim 1 , wherein the administering is oral. 
     
     
       4. The method of  claim 1 , wherein the composition is a solid composition. 
     
     
       5. The method of  claim 1 , wherein the bacteria strain is active. 
     
     
       6. The method of  claim 1 , wherein the composition comprises an antioxidant. 
     
     
       7. The method of  claim 1 , wherein the composition comprises from about 1×10 9  to about 1×10 12  CFU of the bacteria strain. 
     
     
       8. The method of  claim 1 , wherein the composition comprises from about 1×10 3  to about 1×10 11  CFU/g of the bacteria strain with respect to a total weight of the composition. 
     
     
       9. The method of  claim 1 , wherein the subject has one or more of irritable bowel syndrome, Crohn's disease, ulcerative colitis, functional dyspepsia, gastroenteritis, urinary tract infection, and neonatal meningitis. 
     
     
       10. The method of  claim 1 , wherein the subject has diarrhea and not constipation. 
     
     
       11. The method of  claim 1 , wherein the subject has constipation and not diarrhea. 
     
     
       12. The method of  claim 1 , wherein the subject has diarrhea and constipation. 
     
     
       13. The method of  claim 1 , further comprising administering an additional therapeutic agent to the subject. 
     
     
       14. The method of  claim 1 , wherein at least 50% of the bacteria strain as measured by an amount of CFU, remains viable after about 1 year of storage when the composition is stored in a closed container at 25° C. at 95% relative humidity. 
     
     
       15. The method of  claim 1 , wherein the administering reduces a level of hydrogen gas in a breath of the subject by at least 40 ppm, relative to a level of hydrogen gas prior to the administering, as determined by a hydrogen breath test. 
     
     
       16. The method of  claim 1 , wherein the composition is a pharmaceutical composition. 
     
     
       17. The method of  claim 16 , wherein the pharmaceutical composition is comprised in one or more enteric capsules.

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